Senior Associate I - Quality Assurance Systems, Document Control

Catalent Pharma Solutions • Madison, WI

6d • Onsite

About The Position

The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

Requirements

• Master’s degree in STEM discipline with minimum of 0 years related experience.
• Bachelor's Degree in STEM discipline with minimum of 3 years related experience.
• Associates Degree in STEM discipline with minimum of 6 years related experience.
• High School Diploma with a minimum of 7 years related experience.

Responsibilities

• Execution of the Document Management System.
• Manages physical and electronic storage of documents.
• Assures integrity of controlled master documents and executed records.
• Assists with document retrieval during customer audits.
• Performs scanning and filing.
• Manages document workflows to ensure timely document readiness.
• Other duties as assigned.

Benefits

• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED